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9.00 am-12.30 pm TUTORIALS | SATURDAY, OCTOBER 15, 2011DAY 1 | SATURDAY, OCTOBER 15, 2011 Who Will Benefit: • Clinical Project ManagersTutorial # 1: Project Management Metrics • Clinical Research LeadersDuration: 9:00 AM-12:30 PM • Project ManagersinStruCtorS: • Study ManagersNicole M Lee, PMP, PMI-RMP • Clinical Research ManagersDirector of Planning and Analysis, Project Management Office • Clinical Research Project SupportICON Clinical Research, Singapore • CRAs / MonitorsDonald ThampyService Delivery Operations Lead, Accenture, Bangalore, IndiaTutorial Brief: This tutorial has been designed to provide project managers with Tutorial # 2: Advancing Drug Development througha clear understanding of the right project management metrics and its applica- Licensing Opportunities between Pharma, Biotechs,tions in clinical trials. It will provide a clear understanding of project manage- Academia and Investorsment metrics as tools and techniques to monitor and control projects and how Duration: 9:00 AM-12:30 PMthey can be applied to your own pharmaceutical projects in the work place. inStruCtorS:In a tough economy, knowing if a project is on track can make a difference be- Raman Govindarajan, MD, PhDtween profit and loss. Gone are the days of launching projects within a port- Head India R&D; Member Asia Pacific R&D Teamfolio with unclear objectives, poor scheduling and cost estimates, and no way SANOFI, Bangalore, Indiato track progress. Project Managers must understand their organization KPI Shozeb Haider, PhDand ensure the most effective project metrics for measuring these indications. Senior Lecturer, Drug Discovery Center for Cancer Research & Cell BiologyThrough the right project metrics, project managers are equipped with tools Queen’s University, Belfast, UKand techniques to proactively monitor and control their projects. Tutorial Brief: Successful programs in Drug Discovery and Development are of-Learning Objectives: ten a result of close collaboration between pharma, biotechs, academia, and• What is Project Management Monitoring and Control Process and why is it investors. For a country to excel in this field, it is imperative that this relatively important for running clinical trials? complicated machinery is well oiled and the relationships between these stake-• Defining the key characteristics of the project management process and its holders is well understood and well developed. importance to clinical trials Experienced professionals from Industry, Academia, Finance and Legal will con-• Using a project management process for improving the success of your own duct this unique tutorial to elucidate these relationships, highlighting the critical clinical trials enablers of licensing opportunities. Successful examples from the “West” will• Setting clear objectives and defining the scope of your projects be described in detail for the Indian players to have a better understanding of• Aligning the project objectives with the strategic and financial business this subject objectives Learning Objectives:• Understanding the importance of having an overall strategy for your • To understand the benefits of partnerships in drug discovery and research projects development• Developing a detailed project plan to manage your clinical trials • To learn the critical elements of drug licensing• Identifying the key project activities • To learn the key areas where such licensing opportunities exist• Planning a realistic schedule • How and where to find funds for drug discovery and development• Budget planning • How to protect your intellectual property and make the most of it• Implementing risk management and contingency planning • Some thoughts on Translational Research: How to convert your ideas to a• Project implementation and control product• What are project metrics? Who Will Benefit:• Trouble with metrics • R&D teams of pharma and biotech companies• Do your metrics pass the test? • Indian biotech companies that are exploring licensing opportunities• What are the 4 key projects KPIs? • Scientists engaged in basic research• How to apply to your study • Doctors and Scientists who want to conduct Translational Research• Project review and learning for clinical trials • Scientists and Technologists who wish to be entrepreneurs • PhDs and young Scientists who want to conduct “product” driven research • Universities and academic institutions • Policy makers in the government INDIA 2011 | 6th ANNUAL PROGRAM 9

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9.00 am-12.30 pm TUTORIALS CONTINUED | SATURDAY, OCTOBER 15, 2011Tutorial # 3: Adaptive Designs in Clinical Research The key requirements like infrastructure, trained personnel, safety reporting structure, and evaluation tools will be identified and discussed.Duration: 9:00 AM-12:30 PMinStruCtorS: Finally, some of the key concepts in PV like reporting and processing of ADRs, signal detection etc., will be demonstrated through examples and hands onVishwanath (Mahesh) Iyer, PhDHead, Oncology Biometrics exercisesNovartis Healthcare Pvt LtdHyderabad, India Learning Objectives:Instructor Invited • To understand the current practice of PV in IndiaTutorial Brief: This workshop will explore the fast expanding area of adaptive • To learn about the proposed Pharmacovigilance Program of Indiadesigns in clinical research focusing on the statistical questions, as well as some • To see a comparison of PV practices in India versus the developed marketsof the more clinically relevant questions. Discussions will include the following • To understand the gaps in the PV reporting practicestopics: • To identify the key areas of improvements and how to do so1. Guidance from the health authorities – EMEA reflection paper, and the more • To learn the key concepts in pharmacovigilance and how to implement them recent FDA draft guidance in your organization’s PV programs.2. Adaptive Designs in exploratory settings – dose finding studies including Bayesian and CRM designs, and response adaptive randomization Who Will Benefit:3. Adaptive designs in confirmatory settings – sample size re-estimation, • PV Personnel at Pharma companies (Indian as well as multinational) multi-stage designs including group sequential designs, adaptive designs • PV Personnel at CROs with multiple endpoints • Government Regulators4. Seamless designs – Phase IIA/IIB or Phase IIB/III studies, • Medical Advisors / Medical Monitors adaptive studies with treatment selection, adaptive selection (e.g., biomarker • Hospitals and Medical Institutes based enrichment designs) • Practicing Doctors5. Adaptive test procedures based on combination tests, conditional error rate, conditional power, and predictive power • Professionals aspiring to work in the areas of PV Tutorial # 5: Vendor Selection and Oversight, QualityLearning Objectives: and Compliance Considerations• Understanding the regulatory guidelines for adaptive clinical trials Duration: 9:00 AM-12:30 PM• Reviewing common challenges and benefits of adaptive clinical trials inStruCtorS:• Determining when adaptive clinical trials are applicable Jeroze J. Dalal• Assessing statistical considerations for adaptive design GM, Clinical Operations• Examining logistical considerations for implementation such as data GlaxoSmithKline Pharmaceuticals Ltd, Mumbai, India management, recruitment issues, and analysis tools Munish Mehra, PhD• Managing Global Adaptive Clinical Trials President, Global Alliance of Indian Biomedical Professionals Washington DC, USA Who Will Benefit: Tutorial Brief: In recent years, FDA has issued multiple warning letters to• Scientists and Statisticians engaged in designing studies pharmaceutical companies for lack of oversight of their CROs. In addition,• Project Leaders with increased scrutiny and signal detection techniques being used by FDA to• Project Managers detect potential non-compliance, it is critical for sponsors to have appropriate• Regulatory Personnel at Pharma / Biotech / CROs procedures in place for the selection and oversight of their vendors. This tutorial will go over the procedures to be used in selecting vendors and the use of• Regulators engaged in evaluating adaptive studies and their results various study plans, vendor oversight plans, quality management plans, and Key Quality Indicators (KQI’s) to ensure compliance to applicable regulationsTutorial # 4: Building a Drug Safety and and GCPs.Pharmacovigilance Framework in India - From Learning Objectives:Reporting of ADRs to Signal Detection • Understand regulatory requirement for sponsor responsibility of vendorDuration: 9:00 AM-12:30 PM oversightinStruCtorS: • Review recent warning letters where sponsors were citedMoin DonExecutive Director • Review various plans and procedures to oversee vendorsPVCON Pharmacovigilance Services, India, Mumbai, India • Review KQI’s to oversee vendorsVivek Ahuja, MDRegional Director, Asia Pacific, PharmacovigilanceBaxter Healthcare, Gurgaon, India Who Will Benefit: • Sponsor personnel involved in the selection and oversight of vendorsTutorial Brief: This tutorial will cover the essentials of building a robustpharmacovigilance program in India. The instructors will first evaluate the • CROs and other vendors to create best practices and assist their sponsors in oversight and compliance.current structure of PV reporting in the country, including the proposedpharmacovigilance program. Then they will identify the areas whereimprovements can be made.12.30 pm-1.30 pm LUNCH 10 INDIA 2011 | 6th ANNUAL PROGRAM